[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100219715":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":10,"locations":25,"responsibleParty":360,"collaborators":10,"id":362,"slug":363,"hasResults":364,"nctId":365,"briefTitle":366,"officialTitle":367,"acronym":10,"eligibilityCriteria":368,"healthyVolunteers":364,"sex":369,"minAge":370,"maxAge":10,"enrollmentInfo":371,"targetDuration":10,"studyType":374,"phases":10,"briefSummary":375,"conditions":376,"keywords":378,"overallStatus":383,"whyStopped":10,"lastUpdateSubmitDate":384,"lastUpdatePostDateStruct":385,"startDateStruct":387,"completionDateStruct":389,"leadSponsor":391,"locationsCount":392},{"fullName":5,"class":6},"Celgene","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Korean patients",null,"All Korean patients intended to be treated with Vidaza® according to the approved package insert",[13],"Drug: Vidaza®",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DRUG","Vidaza®","The recommended starting dose for the first treatment for all patients regardless of baseline hematology values is Vidaza® 75mg\u002Fm2 subcutaneous(SC) injection or intravenous (IV) infusion, daily for 7 days.",[9],[21],{"name":22,"affiliation":23,"role":24},"Miran Moon","Clinical Research Manager, Celgene Korea","STUDY_DIRECTOR",[26,37,46,55,61,67,73,78,84,93,102,111,116,122,128,134,143,149,158,164,170,179,188,192,201,210,216,225,234,243,249,255,261,267,273,277,283,289,294,300,306,312,318,324,330,336,345,351],{"facility":27,"status":10,"city":28,"state":10,"zip":29,"country":30,"countryCode":10,"cosmosGeoPoint":31,"geoPoint":36,"contacts":10},"Hallym University Sacred Heart Hospital","Anyang","431-796","South Korea",{"type":32,"coordinates":33},"Point",[34,35],127.49001,35.62128,{"lat":35,"lon":34},{"facility":38,"status":10,"city":39,"state":10,"zip":40,"country":30,"countryCode":10,"cosmosGeoPoint":41,"geoPoint":45,"contacts":10},"Soon Chun Hyang University Hospital Bucheon","Bucheon-si","420-853",{"type":32,"coordinates":42},[43,44],126.78306,37.49889,{"lat":44,"lon":43},{"facility":47,"status":10,"city":48,"state":10,"zip":49,"country":30,"countryCode":10,"cosmosGeoPoint":50,"geoPoint":54,"contacts":10},"Kosin University Gospel Hospital","Busan","602-030",{"type":32,"coordinates":51},[52,53],129.03004,35.10168,{"lat":53,"lon":52},{"facility":56,"status":10,"city":48,"state":10,"zip":57,"country":30,"countryCode":10,"cosmosGeoPoint":58,"geoPoint":60,"contacts":10},"Dong-a University Medical Center","602-715",{"type":32,"coordinates":59},[52,53],{"lat":53,"lon":52},{"facility":62,"status":10,"city":48,"state":10,"zip":63,"country":30,"countryCode":10,"cosmosGeoPoint":64,"geoPoint":66,"contacts":10},"Pusan National University Hospital","602-739",{"type":32,"coordinates":65},[52,53],{"lat":53,"lon":52},{"facility":68,"status":10,"city":48,"state":10,"zip":69,"country":30,"countryCode":10,"cosmosGeoPoint":70,"geoPoint":72,"contacts":10},"Inje University Busan Paik Hospital","614-735",{"type":32,"coordinates":71},[52,53],{"lat":53,"lon":52},{"facility":74,"status":10,"city":48,"state":10,"zip":69,"country":30,"countryCode":10,"cosmosGeoPoint":75,"geoPoint":77,"contacts":10},"Inje University Haeundae Paik Hospital",{"type":32,"coordinates":76},[52,53],{"lat":53,"lon":52},{"facility":79,"status":10,"city":48,"state":10,"zip":80,"country":30,"countryCode":10,"cosmosGeoPoint":81,"geoPoint":83,"contacts":10},"Dongnam Inst. of Radiological & Medical Science","619-953",{"type":32,"coordinates":82},[52,53],{"lat":53,"lon":52},{"facility":85,"status":10,"city":86,"state":10,"zip":87,"country":30,"countryCode":10,"cosmosGeoPoint":88,"geoPoint":92,"contacts":10},"Soon Chun Hyang University Hospital Cheonan","Cheonan","330-721",{"type":32,"coordinates":89},[90,91],127.1522,36.8065,{"lat":91,"lon":90},{"facility":94,"status":10,"city":95,"state":10,"zip":96,"country":30,"countryCode":10,"cosmosGeoPoint":97,"geoPoint":101,"contacts":10},"Chungbuk National University Hospital","Cheongju-si","138-736",{"type":32,"coordinates":98},[99,100],127.48972,36.63722,{"lat":100,"lon":99},{"facility":103,"status":10,"city":104,"state":10,"zip":105,"country":30,"countryCode":10,"cosmosGeoPoint":106,"geoPoint":110,"contacts":10},"Keimyung University Dongsan Hospital","Daegu","700-712",{"type":32,"coordinates":107},[108,109],128.59111,35.87028,{"lat":109,"lon":108},{"facility":112,"status":10,"city":104,"state":10,"zip":105,"country":30,"countryCode":10,"cosmosGeoPoint":113,"geoPoint":115,"contacts":10},"Kyungpook National University Hospital",{"type":32,"coordinates":114},[108,109],{"lat":109,"lon":108},{"facility":117,"status":10,"city":104,"state":10,"zip":118,"country":30,"countryCode":10,"cosmosGeoPoint":119,"geoPoint":121,"contacts":10},"Daegu Fatima Hospita","701-010",{"type":32,"coordinates":120},[108,109],{"lat":109,"lon":108},{"facility":123,"status":10,"city":104,"state":10,"zip":124,"country":30,"countryCode":10,"cosmosGeoPoint":125,"geoPoint":127,"contacts":10},"Yeungnam University Medical Center","705-030",{"type":32,"coordinates":126},[108,109],{"lat":109,"lon":108},{"facility":129,"status":10,"city":104,"state":10,"zip":130,"country":30,"countryCode":10,"cosmosGeoPoint":131,"geoPoint":133,"contacts":10},"Daegu Catholic University Medical Center","705-034",{"type":32,"coordinates":132},[108,109],{"lat":109,"lon":108},{"facility":135,"status":10,"city":136,"state":10,"zip":137,"country":30,"countryCode":10,"cosmosGeoPoint":138,"geoPoint":142,"contacts":10},"Chungnam National University Hospital","Daejeon","301-721",{"type":32,"coordinates":139},[140,141],127.38493,36.34913,{"lat":141,"lon":140},{"facility":144,"status":10,"city":136,"state":10,"zip":145,"country":30,"countryCode":10,"cosmosGeoPoint":146,"geoPoint":148,"contacts":10},"Eulji University Hospital - Daejeon","302-799",{"type":32,"coordinates":147},[140,141],{"lat":141,"lon":140},{"facility":150,"status":10,"city":151,"state":10,"zip":152,"country":30,"countryCode":10,"cosmosGeoPoint":153,"geoPoint":157,"contacts":10},"Dongguk University Ilsan Hospital","Goyang","410-773",{"type":32,"coordinates":154},[155,156],127.19731,36.21689,{"lat":156,"lon":155},{"facility":159,"status":10,"city":151,"state":10,"zip":160,"country":30,"countryCode":10,"cosmosGeoPoint":161,"geoPoint":163,"contacts":10},"Inje University Ilsan Paik Hospital","411-706",{"type":32,"coordinates":162},[155,156],{"lat":156,"lon":155},{"facility":165,"status":10,"city":151,"state":10,"zip":166,"country":30,"countryCode":10,"cosmosGeoPoint":167,"geoPoint":169,"contacts":10},"National Health Insurance Service Ilsan Hospital","411-719",{"type":32,"coordinates":168},[155,156],{"lat":156,"lon":155},{"facility":171,"status":10,"city":172,"state":10,"zip":173,"country":30,"countryCode":10,"cosmosGeoPoint":174,"geoPoint":178,"contacts":10},"Chosun University Hospital","Gwangju","501-717",{"type":32,"coordinates":175},[176,177],126.91556,35.15472,{"lat":177,"lon":176},{"facility":180,"status":10,"city":181,"state":10,"zip":182,"country":30,"countryCode":10,"cosmosGeoPoint":183,"geoPoint":187,"contacts":10},"Dongguk University Gyeongju Hospital","Gyeongju","780-350",{"type":32,"coordinates":184},[185,186],129.21167,35.84278,{"lat":186,"lon":185},{"facility":189,"status":10,"city":190,"state":10,"zip":191,"country":30,"countryCode":10,"cosmosGeoPoint":10,"geoPoint":10,"contacts":10},"Hwasun Chonnam National University Hospital","Hwasun-gun","519-809",{"facility":193,"status":10,"city":194,"state":10,"zip":195,"country":30,"countryCode":10,"cosmosGeoPoint":196,"geoPoint":200,"contacts":10},"Wonkwang University Hospital","Iksan","570-711",{"type":32,"coordinates":197},[198,199],126.95444,35.94389,{"lat":199,"lon":198},{"facility":202,"status":10,"city":203,"state":10,"zip":204,"country":30,"countryCode":10,"cosmosGeoPoint":205,"geoPoint":209,"contacts":10},"Inha University Hospital","Incheon","400-711",{"type":32,"coordinates":206},[207,208],126.70515,37.45646,{"lat":208,"lon":207},{"facility":211,"status":10,"city":203,"state":10,"zip":212,"country":30,"countryCode":10,"cosmosGeoPoint":213,"geoPoint":215,"contacts":10},"Gacheon University Gil Hospital","405-760",{"type":32,"coordinates":214},[207,208],{"lat":208,"lon":207},{"facility":217,"status":10,"city":218,"state":10,"zip":219,"country":30,"countryCode":10,"cosmosGeoPoint":220,"geoPoint":224,"contacts":10},"Chonbuk National University Hospital","Jeonju","561-712",{"type":32,"coordinates":221},[222,223],127.14889,35.82194,{"lat":223,"lon":222},{"facility":226,"status":10,"city":227,"state":10,"zip":228,"country":30,"countryCode":10,"cosmosGeoPoint":229,"geoPoint":233,"contacts":10},"Gyeongsang National University Hospital","Jinju","660-702",{"type":32,"coordinates":230},[231,232],128.08472,35.19278,{"lat":232,"lon":231},{"facility":235,"status":10,"city":236,"state":10,"zip":237,"country":30,"countryCode":10,"cosmosGeoPoint":238,"geoPoint":242,"contacts":10},"Inje University Seoul Paik Hospital","Seoul","100-032",{"type":32,"coordinates":239},[240,241],126.9784,37.566,{"lat":241,"lon":240},{"facility":244,"status":10,"city":236,"state":10,"zip":245,"country":30,"countryCode":10,"cosmosGeoPoint":246,"geoPoint":248,"contacts":10},"Seoul National University Hospital","110-744",{"type":32,"coordinates":247},[240,241],{"lat":241,"lon":240},{"facility":250,"status":10,"city":236,"state":10,"zip":251,"country":30,"countryCode":10,"cosmosGeoPoint":252,"geoPoint":254,"contacts":10},"Severance Hospital","120-752",{"type":32,"coordinates":253},[240,241],{"lat":241,"lon":240},{"facility":256,"status":10,"city":236,"state":10,"zip":257,"country":30,"countryCode":10,"cosmosGeoPoint":258,"geoPoint":260,"contacts":10},"Kyunghee University Medical Center","130-702",{"type":32,"coordinates":259},[240,241],{"lat":241,"lon":240},{"facility":262,"status":10,"city":236,"state":10,"zip":263,"country":30,"countryCode":10,"cosmosGeoPoint":264,"geoPoint":266,"contacts":10},"Seoul Medical Center","131-865",{"type":32,"coordinates":265},[240,241],{"lat":241,"lon":240},{"facility":268,"status":10,"city":236,"state":10,"zip":269,"country":30,"countryCode":10,"cosmosGeoPoint":270,"geoPoint":272,"contacts":10},"Samsung Medical Center","135-710",{"type":32,"coordinates":271},[240,241],{"lat":241,"lon":240},{"facility":244,"status":10,"city":236,"state":10,"zip":269,"country":30,"countryCode":10,"cosmosGeoPoint":274,"geoPoint":276,"contacts":10},{"type":32,"coordinates":275},[240,241],{"lat":241,"lon":240},{"facility":278,"status":10,"city":236,"state":10,"zip":279,"country":30,"countryCode":10,"cosmosGeoPoint":280,"geoPoint":282,"contacts":10},"Korea University Anam Hospital","136-705",{"type":32,"coordinates":281},[240,241],{"lat":241,"lon":240},{"facility":284,"status":10,"city":236,"state":10,"zip":285,"country":30,"countryCode":10,"cosmosGeoPoint":286,"geoPoint":288,"contacts":10},"The Catholic University of Korea, Seoul St. Mary's Hospital","137-701",{"type":32,"coordinates":287},[240,241],{"lat":241,"lon":240},{"facility":290,"status":10,"city":236,"state":10,"zip":96,"country":30,"countryCode":10,"cosmosGeoPoint":291,"geoPoint":293,"contacts":10},"Asan Medical Center",{"type":32,"coordinates":292},[240,241],{"lat":241,"lon":240},{"facility":295,"status":10,"city":236,"state":10,"zip":296,"country":30,"countryCode":10,"cosmosGeoPoint":297,"geoPoint":299,"contacts":10},"Korea Cancer Center Hospital","139-706",{"type":32,"coordinates":298},[240,241],{"lat":241,"lon":240},{"facility":301,"status":10,"city":236,"state":10,"zip":302,"country":30,"countryCode":10,"cosmosGeoPoint":303,"geoPoint":305,"contacts":10},"Inje University Sanggye Paik Hospital","139-707",{"type":32,"coordinates":304},[240,241],{"lat":241,"lon":240},{"facility":307,"status":10,"city":236,"state":10,"zip":308,"country":30,"countryCode":10,"cosmosGeoPoint":309,"geoPoint":311,"contacts":10},"Konkuk University Hospital","143-729",{"type":32,"coordinates":310},[240,241],{"lat":241,"lon":240},{"facility":313,"status":10,"city":236,"state":10,"zip":314,"country":30,"countryCode":10,"cosmosGeoPoint":315,"geoPoint":317,"contacts":10},"Korea University Guro Hospital","152-703",{"type":32,"coordinates":316},[240,241],{"lat":241,"lon":240},{"facility":319,"status":10,"city":236,"state":10,"zip":320,"country":30,"countryCode":10,"cosmosGeoPoint":321,"geoPoint":323,"contacts":10},"Boramae Medical Center","156-707",{"type":32,"coordinates":322},[240,241],{"lat":241,"lon":240},{"facility":325,"status":10,"city":236,"state":10,"zip":326,"country":30,"countryCode":10,"cosmosGeoPoint":327,"geoPoint":329,"contacts":10},"Chung-ang University Hospital","156-755",{"type":32,"coordinates":328},[240,241],{"lat":241,"lon":240},{"facility":331,"status":10,"city":236,"state":10,"zip":332,"country":30,"countryCode":10,"cosmosGeoPoint":333,"geoPoint":335,"contacts":10},"Ewha Womans University Mokdong Hospital","158-710",{"type":32,"coordinates":334},[240,241],{"lat":241,"lon":240},{"facility":337,"status":10,"city":338,"state":10,"zip":339,"country":30,"countryCode":10,"cosmosGeoPoint":340,"geoPoint":344,"contacts":10},"The Catholic University of Korea, St. Vicent's Hospital","Suwon","442-723",{"type":32,"coordinates":341},[342,343],127.00889,37.29111,{"lat":343,"lon":342},{"facility":346,"status":10,"city":338,"state":10,"zip":347,"country":30,"countryCode":10,"cosmosGeoPoint":348,"geoPoint":350,"contacts":10},"Ajou University Medical Center","443-721",{"type":32,"coordinates":349},[342,343],{"lat":343,"lon":342},{"facility":352,"status":10,"city":353,"state":10,"zip":354,"country":30,"countryCode":10,"cosmosGeoPoint":355,"geoPoint":359,"contacts":10},"Ulsan University Hospital","Ulsan","682-714",{"type":32,"coordinates":356},[357,358],129.31667,35.53722,{"lat":358,"lon":357},{"type":361,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100219715","post-marketing-surveillance-to-collect-and-evaluate-the-safety-and-efficacy-information-of-korean-mds-patients-treated-with-vidaza-after-approval-of-marketing-authorization-for-new-drug-in-korea-100219715",false,"NCT02137629","Post Marketing Surveillance to Collect and Evaluate the Safety and Efficacy Information of Korean MDS Patients Treated With VIDAZA®, After Approval of Marketing Authorization for New Drug in Korea","VIDAZA® Drug Use Examination","Inclusion Criteria:\n\n* Korean male or female Myelodysplastic Syndrome patients treated with VIDAZA®(subcutaneous or intravenous) according to the approved package insert\n\nExclusion Criteria:\n\n* There's no exclusion criteria","ALL","18 Years",{"count":372,"type":373},511,"ACTUAL","OBSERVATIONAL","The main purpose of VIDAZA® DUE (Drug Use Examination) is to collect and evaluate the safety information of Korean MDS patients treated with VIDAZA®(SC or IV) according to the approved package insert, after approval of marketing authorization for new drug in Korea. In addition, the efficacy information of VIDAZA® in clinical practice is collected and evaluated. This DUE is a prospective, multi-centre, observational, non-interventional, post-marketing surveillance. At least 600 patients' data that is eligible for safety assessment will be collected.\n\nVIDAZA® DUE is to investigate frequency and change of Adverse Events(AEs)\n\n\u002FAdverse Drug Reactions(ADRs), Serious Adverse Events(SAEs)\u002FSerious Adverse Drug Reactions(SADRs), unexpected AE\u002FADR and unexpected SAE\u002FSADR, and to scrutinize factors influencing safety \\& efficacy of the drug. It is necessary to examine patients' demographics and baseline characteristics, medical history, status of VIDAZA treatment, concomitant medication and evaluation of safety and final efficacy (best response) assessment.",[377],"Myelodysplastic Syndrome",[379,380,381,382],"Myelodysplastic syndromes","Vidaza","Observational study","Korea","COMPLETED","2019-11-14",{"date":386,"type":373},"2019-11-18",{"date":388,"type":373},"2010-12-27",{"date":390,"type":373},"2016-05-19",{"name":5,"class":6},48]